Hopping for over-the-counter hearing aids confusing to many

A year ago, the Food and Drug Administration announced new regulations allowing the sale of over-the- counter hearing aids and setting standards for their safety and effectiveness.

That step, which was sup- posed to take three years but required five, portended cheaper high-quality hearing aids that people with mild to moderate hearing loss could buy online or at local phar- macies and big stores.

So how’s it going? It’s a mixed picture.

Manufacturers and retail- ers have become serious about making hearing aids more accessible and affordable. Yet the OTC market remains confusing, if not downright chaotic, for the mostly older consumers the new regulations were intended to help.

The past year also brought renewed focus on the impor- tance of treating hearing loss, which affects two-thirds of people over age 70. Research- ages 70 to 84 with untreated But acquiring quality hear- ers at Johns Hopkins Univer- mild to moderate hearing ing aids over the counter, as sity published the first ran- loss, half received hearing opposed to more expensive domized clinical trial show- assessments from audiolo- prescription devices through ing that hearing aids could gists, were fitted with mid- an audiology practice, can help reduce the pace of cog- priced hearing aids and were still feel challenging. nitive decline. counseled on how to use The FDA reviews “self-fit-

Some background: In them for several months. ting” hearing aids, the kind 2020, the influential Lan- The control group partici- users can customize with a cet Commission on Demen- pated in a health education smartphone app; it has found tia Prevention, Intervention program. eight brands in compliance and Care identified hearing Over three years, the study with regulations since 2022. loss as the greatest poten- found that hearing-aid use A small study recently pub- tially modifiable risk factor had scant effect on healthy lished in JAMA Otolaryngol- for dementia. volunteers at low risk of cog- ogy found that patients who

Previous studies had nitive loss. But among partic- were given a commercially demonstrated a link between ipants who were older and available, self-fitting hearing hearing loss and cognitive less affluent, hearing aids aid in a clinical trial could, decline, said Dr. Frank Lin, reduced the rate of cognitive after six weeks, hear as well an otolaryngologist and pub- decline by 48%, compared as patients fitted with the lic health researcher at Johns with the control group, a same device by audiologists. Hopkins and lead author of difference the researchers But not everyone with the new research. deemed “clinically mean- hearing loss feels comfort-

“What remained unan- ingful.” able with online sales and swered was, If we treat This subset of partici- do-it-yourself adjustments hearing loss, does it actu- pants had lower incomes via apps. And devices that ally reduce cognitive loss?” and “were older, less edu- aren’t self-fitting, and instead he said. The ACHIEVE study cated, with higher rates of use preset controls, don’t

ing and Cognitive Health diabetes and hypertension,” undergo FDA review at all. Evaluation in Elders) showed Lin said. Because such fac“It’s still Day 1 of the mar- that, at least for a particu- tors are also associated with ket’s opening,” said Barbara lar group of older adults, dementia, “the people at Kelley, executive director of it could. higher risk really stand to the Hearing Loss Association

Of nearly 1,000 people benefit the most,” he said. of America, an advocacy and support group. “The price neered by Bose, is encourpoints are all over. There’s aged by its findings that 94% still confusion among con- of those buyers are first-time sumers.” purchasers.

Still, progress. Self-fitting “We’re finally able to OTC aids that perform well access a part of the market are now widely available for that was previously unpeneabout $1,000 a pair; prescrip- trated because of the costs,” tion hearing aids purchased she said. The company projthrough audiologists cost ects sales of 260,000 pairs several times more. next year and 1 million per

Perhaps because older year in 2027.

Americans don’t know about To help guide buyers, or mistrust the new over-the- HearAdvisor — a company counter devices, or because founded by two audiologists they still find the price a bar- and a hearing scientist — has rier, initial sales appear mod- built an independent acousest. (Traditional Medicare tic lab in Rockford, Illinois, doesn’t cover hearing aids; to evaluate and rank both Medicare Advantage plans prescription and OTC hearoffering hearing benefits still ing aids for those with mild leave patients paying most to moderate loss. of the costs.) After testing about 50

Lexie Hearing, a major devices to date, HearAdvimanufacturer, sells self-fitting sor gave its “Expert Choice” OTC devices for $799 to $999 award to 13. In general, OTC a pair online and in 14,000 devices that cost $1,000 or stores nationwide. Accord- more perform well, Sabin ing to Seline van der Wat, said, while those sold online the chief operating officer, today for under $500 “are the company is on track to most often junk.” The Hearsell 90,000 pairs this year. ing Loss Association has

But Lexie, whose hearing planned a series of webiaids are designed and engi- nars called OTC 101.